FDA-Device2026-07-29Class IIPROCESSING DEFECT
Penumbra System RED 68 Reperfusion Catheter recalled for fracture risk due to manufacturing defect
What this means
Penumbra System RED 68 Reperfusion Catheters (REF: RED68KIT) may fracture during use due to a manufacturing defect. The affected lots are H00008699, H00008701, H00008702, H00008703, and C00020038. These catheters were distributed worldwide, including throughout the United States.
- If you use or have access to affected RED 68 catheters, stop using them immediately.
- Contact Penumbra, Inc. for instructions on device return or replacement.
- Healthcare facilities should verify lot numbers against the affected list and quarantine any matching inventory.
The agency's original wording
Hazard
Due to manufacturing issues, reperfusion catheters may fractures
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide - US Nationwide distribution including in the states and territories of AK, AL, AE, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, Puerto Rico and the countries of Brazil, Canada, Colombia, Ecuador, Indonesia, Israel, Lebanon, Mexico, Mongolia, Philippines, Saudi Arabia, Thailand, and United Arab Emirates.
Affected count
N/A
Manufactured in
6262 Patterson Pass Rd Ste A, N/A, Livermore, CA, United States
Products
Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2770-2026Want us to check the next one for you?
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